MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-10 for Q2 CHECKMATE EXTENSION SET 9545 manufactured by Quest Medical, Inc..
[52745419]
Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[52745420]
The hospital reported an issue encountered with the intravenous administration extension set during use. The report stated that some of the luer locks do not appear to have a fixed stopping point- like they have been stripped out. The report stated that as a result the infusion sets would then come off of the manifold during the procedures, causing a delay in the procedure while the issue was remedied. The complainant reported that out of (b)(4) eaches in a box of the product they have had issues with at least (b)(4) of the devices. A complaint sample has been returned to the manufacturer for analysis. There were no patient complications reported as a result of the alleged event.
Patient Sequence No: 1, Text Type: D, B5
[55491089]
Visual examination of the complaint sample found that the tubing from the checkmate component appears to have been removed and re-configured by the customer. The cap on the checkmate rotated as if it did not have any threads. Further examination found that the threads appeared distorted either from over-tightening or by repeated threading onto other ports. It is likely the luer on non-quest tubing could have distorted the hub threading. The device history record for the lot and subcomponent lot(s) were reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2016-00039 |
| MDR Report Key | 5865131 |
| Date Received | 2016-08-10 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-07-13 |
| Date Mfgr Received | 2016-07-14 |
| Device Manufacturer Date | 2015-12-09 |
| Date Added to Maude | 2016-08-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Q2 CHECKMATE EXTENSION SET |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2016-08-10 |
| Returned To Mfg | 2016-07-20 |
| Model Number | 9545 |
| Lot Number | 0502535D06 |
| Device Expiration Date | 2018-12-08 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-10 |